A Phase 3 interventional study of GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 and Engerix-B™ vaccine in Malaria and Malaria Vaccines, sponsored by GlaxoSmithKline. Completed at 2 sites in 2 countries. Open to participants aged 8 Weeks to 12 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-18.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
This study has been designed to support the indication of the candidate vaccine (also referred to as GSK 257049 or RTS,S in this record) against hepatitis B virus infection, when administered as a primary vaccination integrated into an Expanded Program on Immunization (EPI) regimen to infants living in sub-Saharan Africa.
1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.
This study's enrollment of 705 is above the median of 120 across 1,187 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
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All subjects must satisfy ALL the following criteria at study entry:
Exclusion Criteria:
The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen A, with the RTS,S vaccine administered in its Lot 1 formulation. This RTS,S Vaccination Regimen A included 3 doses of RTS,S vaccine, Lot 1, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 · Biological: Engerix-B™ vaccine · Biological: Infanrix/Hib™ vaccine · Biological: Polio Sabin™ vaccine · Biological: Rotarix™ vaccine · Biological: Synflorix™ vaccine · Biological: Measles vaccine · Biological: Yellow fever vaccine
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen A, with the RTS,S vaccine administered in its Lot 2 formulation. This RTS,S Vaccination Regimen A included 3 doses of RTS,S vaccine, Lot 2, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 · Biological: Engerix-B™ vaccine · Biological: Infanrix/Hib™ vaccine · Biological: Polio Sabin™ vaccine · Biological: Rotarix™ vaccine · Biological: Synflorix™ vaccine · Biological: Measles vaccine · Biological: Yellow fever vaccine
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen A, with the RTS,S vaccine administered in its Lot 3 formulation. This RTS,S Vaccination Regimen A included 3 doses of RTS,S vaccine, Lot 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 · Biological: Engerix-B™ vaccine · Biological: Infanrix/Hib™ vaccine · Biological: Polio Sabin™ vaccine · Biological: Rotarix™ vaccine · Biological: Synflorix™ vaccine · Biological: Measles vaccine · Biological: Yellow fever vaccine
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen B, with the RTS,S vaccine administered in its Lot 1 formulation. This RTS,S Vaccination Regimen B included 3 doses of RTS,S vaccine, Lot 1, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 · Biological: Engerix-B™ vaccine · Biological: Infanrix/Hib™ vaccine · Biological: Polio Sabin™ vaccine · Biological: Rotarix™ vaccine · Biological: Synflorix™ vaccine · Biological: Measles vaccine · Biological: Yellow fever vaccine
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen B, with the RTS,S vaccine administered in its Lot 2 formulation. This RTS,S Vaccination Regimen B included 3 doses of RTS,S vaccine, Lot 2, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 · Biological: Engerix-B™ vaccine · Biological: Infanrix/Hib™ vaccine · Biological: Polio Sabin™ vaccine · Biological: Rotarix™ vaccine · Biological: Synflorix™ vaccine · Biological: Measles vaccine · Biological: Yellow fever vaccine
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen B, with the RTS,S vaccine administered in its Lot 3 formulation. This RTS,S Vaccination Regimen B included 3 doses of RTS,S vaccine, Lot 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 · Biological: Engerix-B™ vaccine · Biological: Infanrix/Hib™ vaccine · Biological: Polio Sabin™ vaccine · Biological: Rotarix™ vaccine · Biological: Synflorix™ vaccine · Biological: Measles vaccine · Biological: Yellow fever vaccine
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen C, with the RTS,S vaccine administered in its Lot 1 formulation. This RTS,S Vaccination Regimen C included 3 doses of RTS,S vaccine, Lot 1, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 · Biological: Engerix-B™ vaccine · Biological: Infanrix/Hib™ vaccine · Biological: Polio Sabin™ vaccine · Biological: Rotarix™ vaccine · Biological: Synflorix™ vaccine · Biological: Measles vaccine · Biological: Yellow fever vaccine
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen C, with the RTS,S vaccine administered in its Lot 2 formulation. This RTS,S Vaccination Regimen C included 3 doses of RTS,S vaccine, Lot 2, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 · Biological: Engerix-B™ vaccine · Biological: Infanrix/Hib™ vaccine · Biological: Polio Sabin™ vaccine · Biological: Rotarix™ vaccine · Biological: Synflorix™ vaccine · Biological: Measles vaccine · Biological: Yellow fever vaccine
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen C, with the RTS,S vaccine administered in its Lot 3 formulation. This RTS,S Vaccination Regimen C included 3 doses of RTS,S vaccine, Lot 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 · Biological: Engerix-B™ vaccine · Biological: Infanrix/Hib™ vaccine · Biological: Polio Sabin™ vaccine · Biological: Rotarix™ vaccine · Biological: Synflorix™ vaccine · Biological: Measles vaccine · Biological: Yellow fever vaccine
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Biological: Engerix-B™ vaccine · Biological: Infanrix/Hib™ vaccine · Biological: Polio Sabin™ vaccine · Biological: Rotarix™ vaccine · Biological: Synflorix™ vaccine · Biological: Measles vaccine · Biological: Yellow fever vaccine
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Biological: Engerix-B™ vaccine · Biological: Infanrix/Hib™ vaccine · Biological: Polio Sabin™ vaccine · Biological: Rotarix™ vaccine · Biological: Synflorix™ vaccine · Biological: Measles vaccine · Biological: Yellow fever vaccine
Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection.
Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
Percentage of Seroprotected Subjects Against Anti-Hepatitis B (HBs) Antigen
A seroprotected subject was defined as a subject with anti-HBs antibody titers greater than or equal to (\>=) the cut-off of 10 mili-international units per mililiter (mIU/mL). A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, with study groups pooled by primary vaccine administered (RTS,S vs Engerix -B).
Time frame: At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B
Anti-Hepatitis B (HBs) Antibody Concentrations for RTS,S Group and Engerix B Group
Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (\>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, with study groups pooled by primary vaccine administered (RTS,S vs Engerix-B).
Time frame: At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B
Anti-Hepatitis B (HBs) Antibody Concentrations for All Study Groups
Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (\>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, for each RTS,S Regimen A, B, C and each Engerix B Regimen A and B study groups.
Time frame: At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B
Anti-Hepatitis B (HBs) Antibody Concentrations at Month 3
Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (\>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Results presented are for the study groups receiving the RTS,S vaccine, pooled by vaccine lot, that is, for the RTS,S Lot 1, RTS,S Lot 2, and RTS,S Lot 3 groups, as defined below.
Time frame: At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B
Anti-Hepatitis B (HBs) Antibody Concentrations at Month 14 and 26
Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (\>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Results presented are for each RTS,S Regimen A, B \& C, and for each Engerix B Regimen A \& B study groups.
Time frame: At Months 14 and 26, aka at 12 and 24 months post Dose 3 of RTS,S vaccine or Engerix-B
Anti-Hepatitis B (HBs) Antibody Concentrations at Month 38, 50 and 51
Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (\>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Results presented are for each RTS,S Regimen A, B \& C, and for each Engerix B Regimen A \& B study groups.
Time frame: At Months 38, 50 and 51, aka 36 and 48 months post Dose 3 of RTS,S vaccine or Engerix-B and one month post the Month 50 booster dose of Engerix-B
Concentrations of Antibodies to the Hepatitis B RF1 Surface Antigen (Anti-HBs RF1) at Month 3
Anti-HBs RF1 antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (\>=) 33 EL.U/mL. The table shows results for each RTS,S Regimen A, B \& C, and for each Engerix B Regimen A \& B study groups.
Time frame: At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B
Concentrations of Antibodies to the Hepatitis B RF1 Surface Antigen (Anti-HBs RF1) at Month 51
Anti-HBs RF1 antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (\>=) 33 EL.U/mL. The table shows results for each RTS,S Regimen A, B \& C, and for each Engerix B Regimen A \& B study groups.
Time frame: At Month 51, aka one month post the Month 50 booster dose of Engerix-B
Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations at Month 3
Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (\>=) 0.5 EL.U/mL. The table shows results for each RTS,S Regimen A, B \& C, and for each Engerix B Regimen A \& B study groups.
Time frame: At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B
Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations at Month 14
Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (\>=) 0.5 EL.U/mL. The table shows results for each RTS,S Regimen A, B \& C, and for each Engerix B Regimen A \& B study groups. No anti-CS results are available for the time point 24 months post Dose 3 (Month 26) because the quantity of serum available for the anti-CS assay was insufficient for many samples.
Time frame: At Month 14, aka at 12 months post Dose 3 of RTS,S vaccine or Engerix-B
Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations at Month 38 and 50
Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (\>=) 1.9 EL.U/mL. The table shows results for each RTS,S Regimen A, B \& C, and for each Engerix B Regimen A \& B study groups.
Time frame: At Months 38 and 50, aka 36 and 48 months post Dose 3 of RTS,S vaccine or Engerix-B
Pneumococcal Antibody Concentrations Against Synflorix Pneumococcal Vaccine Serotypes at Month 3
Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), and expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay, by GSK assay, was greater than or equal to (\>=) 0.2 µg/mL. This corresponds to the standard ELISA value of 0.35 μg/mL. This outcome concerns the subjects who received the RTS,S or Engerix-B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups.
Time frame: At Month 3, aka at one month post Dose 3 of Synflorix
Pneumococcal Antibody Concentrations Against Synflorix Pneumococcal Vaccine Serotypes at Month 17
Antibody concentrations were measured by GSK assay, and expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay, by GSK assay, was greater than or equal to (\>=) 0.2 μg/mL. This corresponds to the standard ELISA value of 0.35 μg/mL. This outcome concerns the subjects who received the RTS,S or Engerix -B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix -B Regimen A groups.
Time frame: At Month 17, aka one month post the Month 16 booster dose of Synflorix
Titers for Opsonophagocytic Activity Against Synflorix Pneumococcal Vaccine Serotypes at Month 3
The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Streptococcus pneumoniae opsonophagocytic activity was presented as the dilution of serum (opsonic titer) able to sustain 50 % killing of live pneumococci under the assay conditions, expressed as geometric mean titers (GMTs). The cut-off of the assay was an opsonic dilution \>= 8. This outcome concerns the subjects who received the RTS,S or Engerix-B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups.
Time frame: At Month 3, aka at one month (1M) post Dose 3 of Synflorix
Titers for Opsonophagocytic Activity Against Synflorix Pneumococcal Vaccine Serotypes at Month 17
The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Streptococcus pneumoniae opsonophagocytic activity was presented as the dilution of serum (opsonic titer) able to sustain 50 % killing of live pneumococci under the assay conditions, expressed as geometric mean titers (GMTs). The cut-off of the assay was an opsonic dilution \>= 8. This outcome concerns the subjects who received the RTS,S or Engerix -B vaccine co-administered with Synflorix . Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix -B Regimen A groups.
Time frame: At Month 17, aka one month post the Month 16 booster dose of Synflorix
Anti-protein D (PD) Antibody Concentrations at Month 3
Anti-PD antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to 100 EL.U/mL. This outcome concerns the subjects who received the RTS,S or Engerix-B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups.
Time frame: At Month 3, aka at one month post Dose 3 of Synflorix
Anti-protein D (PD) Antibody Concentrations at Month 17
Anti-PD antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to 100 EL.U/mL. This outcome concerns the subjects who received the RTS,S or Engerix -B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix -B Regimen A groups.
Time frame: At Month 17, aka one month post the Month 16 booster dose of Synflorix
Concentrations of Antibodies Against Acellular B-pertussis (BPT) at Day 0 and at Month 3
The antibodies against BPT assessed were against pertussis toxoid (anti-PT), against filamentous haemagglutinin (anti-FHA), and against pertactin (anti-PRN). Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to (\>=) 5 EL.U/mL. The table shows results for study groups pooled by primary vaccine administered (RTS,S vs Engerix -B)
Time frame: At Day 0 and at Month 3 (one month post Dose 3 of Infanrix-Hib)
Anti-Rotavirus (Anti-RV) Antibody Concentrations
Anti-Rotavirus (anti-RV) antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs). The cut-off of the assay was the seropositive cut-off value of greater than or equal to (\>=) 20 units per milliliter (U/mL). This outcome measure was assessed in subjects who were administered Rotarix as part of an EPI regimen, with and without RTS,S vaccine co-administration. This outcome concerns the subjects who received the RTS,S or Engerix-B vaccine co-administered with Rotarix. Results presented are for the study groups pooled by RTS,S or Engerix-B vaccine co-administration, that is, for the RTS,S Regimen B and Engerix-B Regimen B groups.
Time frame: At Month 3, aka one month post Dose 2 of Rotarix
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling at the site of injection. All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination. Analysis for this outcome was performed solely for the 7-days follow-up periods following the primary vaccination with RTS,S vaccine or Engerix-B (at Day 0, and Months 1 and 2). Data presented are those for any occurrence of the assessed solicited local symptoms, that is, the occurrences of these symptoms regardless of their intensity grade.
Time frame: Within the 7-day follow-up period (Days 0-6) after administration of Dose (D) 1, 2 and 3, respectively, with RTS,S or Engerix-B vaccine
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. Fever was defined as axillary temperature higher than (\>) 37.5 degrees Celsius (°C). Analysis for this outcome was performed solely for the 7-days follow-up periods following the primary vaccination with RTS,S vaccine or Engerix-B (at Day 0, and Months 1 and 2). Data presented are those for any occurrence of the assessed solicited general symptoms, that is, the occurrences of these symptoms regardless of their intensity grade or relationship to vaccination.
Time frame: Within the 7-day follow-up period (Days 0-6) after administration of Dose (D) 1, 2 and 3, respectively, with RTS,S or Engerix-B vaccine
Number of Subjects With Potential Immune Mediated Disorders (pIMDs) From Day 0 to Month 8
A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison's disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis.
Time frame: From Day 0 to Month 8
Number of Subjects With Potential Immune Mediated Disorders (pIMDs) From Day 0 to Month 26
A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison's disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis.
Time frame: From Day 0 to Month 26
Number of Subjects With Potential Immune Mediated Disorders (pIMDs) From Day 0 up to Study End (Month 51)
A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison's disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis.
Time frame: From Day 0 up to Study End (Month 51)
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: Within the 30-day follow-up periods (Days 0-29) after vaccination with RTS,S vaccine or Engerix-B
Number of Subjects With Any and Fatal Serious Adverse Events (SAEs) Within the 30-day Follow-up Periods (Days 0-29)
A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.
Time frame: Within the 30-day follow-up periods (Days 0-29) after vaccination with RTS,S vaccine or Engerix-B
Number of Subjects With Any and Fatal Serious Adverse Events (SAEs) From Day 0 to Month 8
A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.
Time frame: From Day 0 to Month 8
Number of Subjects With Any and Fatal Serious Adverse Events (SAEs) From Day 0 to Month 26
A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.
Time frame: From Day 0 to Month 26
Number of Subjects With Any, Fatal and Related Serious Adverse Events (SAEs) From Day 0 up to Study End (Month 51)
A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject. A related SAE was defined as a SAE assessed by the investigator as being causally related to vaccination.
Time frame: From Day 0 up to Study End (Month 51)
The study was conducted in 4 phases, a Primary Vaccination Phase (up to Month (M) 3), a Safety Follow-Up Phase (M3-8), a First Immunogenicity Follow-Up (FU) Phase (M8-26), and a Second Immunogenicity FU Phase (M26 to study end at M51).
| Milestone | RTS,S Regimen A Group | RTS,S Regimen B Group | RTS,S Regimen C Group | Engerix B Regimen A Group | Engerix B Regimen B Group |
|---|---|---|---|---|---|
| Started | 142 | 142 | 141 | 141 | 139 |
| Completed | 131 | 128 | 123 | 132 | 129 |
| Not completed | 11 | 14 | 18 | 9 | 10 |
| Withdrew: Adverse event | 3 | 5 | 4 | 2 | 1 |
| Withdrew: Lost to follow-up | 8 | 9 | 14 | 7 | 9 |
A seroprotected subject was defined as a subject with anti-HBs antibody titers greater than or equal to (\>=) the cut-off of 10 mili-international units per mililiter (mIU/mL). A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, with study groups pooled by primary vaccine administered (RTS,S vs Engerix -B).
| Percentage of subjects | RTS,S Group | Engerix B Group |
|---|---|---|
| Percentage of Seroprotected Subjects Against Anti-Hepatitis B (HBs) Antigen | 100 (99.1 to 100) | 96 (92.9 to 98.1) |
Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (\>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, with study groups pooled by primary vaccine administered (RTS,S vs Engerix-B).
| mIU/mL | RTS,S Group | Engerix B Group |
|---|---|---|
| Anti-Hepatitis B (HBs) Antibody Concentrations for RTS,S Group and Engerix B Group | 6412.7 (5732.9 to 7173.0) | 377.4 (310.6 to 458.7) |
Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (\>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, for each RTS,S Regimen A, B, C and each Engerix B Regimen A and B study groups.
| mIU/mL | RTS,S Regimen A Group | RTS,S Regimen B Group | RTS,S Regimen C Group | Engerix B Regimen A Group | Engerix B Regimen B Group |
|---|---|---|---|---|---|
| Anti-Hepatitis B (HBs) Antibody Concentrations for All Study Groups | 5467.6 (4493.8 to 6652.5) | 6989.9 (5747.5 to 8501.0) | 6998.7 (5779.1 to 8475.7) | 334.4 (253.4 to 441.4) | 433.4 (329.5 to 570.1) |
Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (\>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Results presented are for the study groups receiving the RTS,S vaccine, pooled by vaccine lot, that is, for the RTS,S Lot 1, RTS,S Lot 2, and RTS,S Lot 3 groups, as defined below.
| mIU/mL | RTS,S Lot 1 Group | RTS,S Lot 2 Group | RTS,S Lot 3 Group |
|---|---|---|---|
| Anti-Hepatitis B (HBs) Antibody Concentrations at Month 3 | 6214.3 (5115.6 to 7548.9) | 6826.1 (5569.4 to 8366.3) | 6209.2 (5144.2 to 7494.8) |
Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (\>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Results presented are for each RTS,S Regimen A, B \& C, and for each Engerix B Regimen A \& B study groups.
| mIU/mL | RTS,S Regimen A Group | RTS,S Regimen B Group | RTS,S Regimen C Group | Engerix B Regimen A Group | Engerix B Regimen B Group |
|---|---|---|---|---|---|
| Anti-HBs - At Month 14 | 1530.1 (1259.4 to 1859.1) | 2430.9 (1975.7 to 2991.0) | 2189.1 (1840.3 to 2603.9) | 119.5 (91.0 to 157.0) | 137.5 (103.3 to 183.2) |
| Anti-HBs - At Month 26 | 1092.6 (867.4 to 1376.3) | 1896.0 (1487.2 to 2417.3) | 1849.8 (1478.9 to 2313.6) | 68.8 (50.7 to 93.3) | 71.0 (51.6 to 97.8) |
Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (\>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Results presented are for each RTS,S Regimen A, B \& C, and for each Engerix B Regimen A \& B study groups.
| mIU/mL | RTS,S Regimen A Group | RTS,S Regimen B Group | RTS,S Regimen C Group | Engerix B Regimen A Group | Engerix B Regimen B Group |
|---|---|---|---|---|---|
| Month 38 | 706.8 (548.0 to 911.6) | 1081.7 (845.3 to 1384.2) | 977.4 (786.7 to 1214.3) | 39.0 (29.0 to 52.4) | 41.2 (29.8 to 57.0) |
| Month 50 | 499.4 (382.2 to 652.6) | 765.3 (590.5 to 992.0) | 807.3 (649.6 to 1003.4) | 29.2 (22.0 to 38.7) | 32.9 (23.9 to 45.4) |
| Month 51 | 32345.9 (24758.5 to 42258.4) | 54977.1 (43579.1 to 69356.4) | 59630.0 (48606.1 to 73154.0) | 8995.0 (5935.8 to 13631.0) | 9578.9 (6374.2 to 14395.0) |
Anti-HBs RF1 antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (\>=) 33 EL.U/mL. The table shows results for each RTS,S Regimen A, B \& C, and for each Engerix B Regimen A \& B study groups.
| EL.U/mL | RTS,S Regimen A Group | RTS,S Regimen B Group | RTS,S Regimen C Group | Engerix B Regimen A Group | Engerix B Regimen B Group |
|---|---|---|---|---|---|
| Concentrations of Antibodies to the Hepatitis B RF1 Surface Antigen (Anti-HBs RF1) at Month 3 | 268.7 (226.8 to 318.3) | 327.1 (272.2 to 393.1) | 335.5 (283.2 to 397.5) | 25.5 (22.8 to 28.7) | 28.7 (24.6 to 33.4) |
Anti-HBs RF1 antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (\>=) 33 EL.U/mL. The table shows results for each RTS,S Regimen A, B \& C, and for each Engerix B Regimen A \& B study groups.
| EL.U/mL | RTS,S Regimen A Group | RTS,S Regimen B Group | RTS,S Regimen C Group | Engerix B Regimen A Group | Engerix B Regimen B Group |
|---|---|---|---|---|---|
| Concentrations of Antibodies to the Hepatitis B RF1 Surface Antigen (Anti-HBs RF1) at Month 51 | 307.8 (239.0 to 396.4) | 471.6 (372.5 to 597.1) | 514.5 (415.3 to 637.5) | 120.5 (86.6 to 167.6) | 127.9 (94.5 to 173.1) |
Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (\>=) 0.5 EL.U/mL. The table shows results for each RTS,S Regimen A, B \& C, and for each Engerix B Regimen A \& B study groups.
| EL.U/mL | RTS,S Regimen A Group | RTS,S Regimen B Group | RTS,S Regimen C Group | Engerix B Regimen A Group | Engerix B Regimen B Group |
|---|---|---|---|---|---|
| Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations at Month 3 | 142.2 (116.4 to 173.7) | 188.5 (156.5 to 227.0) | 205.5 (167.3 to 252.5) | 0.3 (0.3 to 0.3) | 0.3 (0.3 to 0.4) |
Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (\>=) 0.5 EL.U/mL. The table shows results for each RTS,S Regimen A, B \& C, and for each Engerix B Regimen A \& B study groups. No anti-CS results are available for the time point 24 months post Dose 3 (Month 26) because the quantity of serum available for the anti-CS assay was insufficient for many samples.
| EL.U/mL | RTS,S Regimen A Group | RTS,S Regimen B Group | RTS,S Regimen C Group | Engerix B Regimen A Group | Engerix B Regimen B Group |
|---|---|---|---|---|---|
| Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations at Month 14 | 5.7 (4.2 to 7.7) | 6.8 (5.0 to 9.4) | 7.5 (5.3 to 10.6) | 0.3 (0.3 to 0.3) | 0.3 (0.3 to 0.4) |
Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (\>=) 1.9 EL.U/mL. The table shows results for each RTS,S Regimen A, B \& C, and for each Engerix B Regimen A \& B study groups.
| EL.U/mL | RTS,S Regimen A Group | RTS,S Regimen B Group | RTS,S Regimen C Group | Engerix B Regimen A Group | Engerix B Regimen B Group |
|---|---|---|---|---|---|
| Month 38 | 2.6 (2.2 to 3.1) | 2.8 (2.3 to 3.4) | 3.5 (2.9 to 4.2) | 1.0 (1.0 to 1.1) | 1.0 (1.0 to 1.0) |
| Month 50 | 2.3 (2.0 to 2.7) | 2.4 (2.0 to 2.8) | 2.7 (2.3 to 3.2) | 1.1 (1.0 to 1.1) | 1.1 (1.0 to 1.3) |
Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), and expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay, by GSK assay, was greater than or equal to (\>=) 0.2 µg/mL. This corresponds to the standard ELISA value of 0.35 μg/mL. This outcome concerns the subjects who received the RTS,S or Engerix-B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups.
| µg/mL | RTS,S Regimen A Group | Engerix B Regimen A Group |
|---|---|---|
| ANTI-1 | 3.1 (2.8 to 3.6) | 3.6 (3.1 to 4.2) |
| ANTI-4 | 3.5 (3.0 to 4.0) | 4.2 (3.5 to 4.9) |
| ANTI-5 | 5.1 (4.5 to 5.8) | 6.5 (5.6 to 7.4) |
| ANTI-6B | 1.1 (0.8 to 1.3) | 1.2 (1.0 to 1.6) |
| ANTI-7F | 4.4 (3.9 to 4.9) | 4.9 (4.3 to 5.7) |
| ANTI-9V | 2.8 (2.4 to 3.3) | 3.7 (3.3 to 4.2) |
| ANTI-14 | 5.8 (5.0 to 6.7) | 5.7 (4.7 to 7.0) |
| ANTI-18C | 3.4 (2.8 to 4.1) | 6.2 (5.1 to 7.5) |
| ANTI-19F | 4.2 (3.4 to 5.2) | 5.1 (4.1 to 6.4) |
| ANTI-23F | 1.3 (1.1 to 1.6) | 1.5 (1.1 to 1.9) |
Antibody concentrations were measured by GSK assay, and expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay, by GSK assay, was greater than or equal to (\>=) 0.2 μg/mL. This corresponds to the standard ELISA value of 0.35 μg/mL. This outcome concerns the subjects who received the RTS,S or Engerix -B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix -B Regimen A groups.
| μg/mL | RTS,S Regimen A Group | Engerix B Regimen A Group |
|---|---|---|
| ANTI-1 | 4.5 (3.8 to 5.4) | 5.4 (4.5 to 6.4) |
| ANTI-4 | 6.1 (5.1 to 7.2) | 6.8 (5.7 to 8.0) |
| ANTI-5 | 6.5 (5.5 to 7.8) | 7.6 (6.4 to 9.1) |
| ANTI-6B | 4.7 (4.0 to 5.5) | 4.1 (3.5 to 4.9) |
| ANTI-7F | 7.1 (6.2 to 8.2) | 7.2 (6.3 to 8.2) |
| ANTI-9V | 6.0 (5.1 to 7.1) | 5.7 (4.9 to 6.6) |
| ANTI-14 | 9.0 (7.6 to 10.7) | 9.0 (7.4 to 10.8) |
| ANTI-18C | 13.7 (11.5 to 16.3) | 14.5 (12.3 to 17.2) |
| ANTI-19F | 6.0 (4.9 to 7.4) | 7.2 (5.8 to 8.8) |
| ANTI-23F | 4.1 (3.4 to 5.1) | 3.9 (3.2 to 4.8) |
The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Streptococcus pneumoniae opsonophagocytic activity was presented as the dilution of serum (opsonic titer) able to sustain 50 % killing of live pneumococci under the assay conditions, expressed as geometric mean titers (GMTs). The cut-off of the assay was an opsonic dilution \>= 8. This outcome concerns the subjects who received the RTS,S or Engerix-B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups.
| Titer | RTS,S Regimen A Group | Engerix B Regimen A Group |
|---|---|---|
| OPSONO-1 | 48.9 (34.6 to 68.9) | 65.0 (45.0 to 93.7) |
| OPSONO-4 | 768.3 (617.6 to 955.8) | 810.9 (676.5 to 972.0) |
| OPSONO-5 | 77.6 (61.9 to 97.3) | 93.8 (73.6 to 119.6) |
| OPSONO-6B | 444.4 (295.0 to 669.5) | 389.3 (250.1 to 606.1) |
| OPSONO-7F | 3774.0 (3232.7 to 4405.8) | 3947.4 (3338.3 to 4667.7) |
| OPSONO-9V | 1257.7 (977.3 to 1618.7) | 1469.3 (1180.4 to 1828.8) |
| OPSONO-14 | 1426.3 (1136.0 to 1790.9) | 1269.0 (965.1 to 1668.6) |
| OPSONO-18C | 192.6 (139.2 to 266.4) | 249.7 (185.0 to 337.0) |
| OPSONO-19F | 159.3 (109.9 to 231.0) | 228.8 (160.4 to 326.3) |
| OPSONO-23F | 760.9 (476.3 to 1215.5) | 735.6 (456.3 to 1185.9) |
The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Streptococcus pneumoniae opsonophagocytic activity was presented as the dilution of serum (opsonic titer) able to sustain 50 % killing of live pneumococci under the assay conditions, expressed as geometric mean titers (GMTs). The cut-off of the assay was an opsonic dilution \>= 8. This outcome concerns the subjects who received the RTS,S or Engerix -B vaccine co-administered with Synflorix . Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix -B Regimen A groups.
| Titer | RTS,S Regimen A Group | Engerix B Regimen A Group |
|---|---|---|
| OPSONO-1 | 649.9 (464.7 to 908.9) | 840.1 (603.4 to 1169.7) |
| OPSONO-4 | 2347.1 (1847.4 to 2982.0) | 2527.8 (2064.1 to 3095.7) |
| OPSONO-5 | 324.2 (244.1 to 430.5) | 392.8 (291.3 to 529.6) |
| OPSONO-6B | 955.3 (761.4 to 1198.6) | 828.2 (652.7 to 1050.9) |
| OPSONO-7F | 9167.3 (7979.2 to 10532.3) | 7794.6 (6577.6 to 9236.8) |
| OPSONO-9V | 3035.3 (2523.3 to 3651.3) | 3164.6 (2669.8 to 3751.1) |
| OPSONO-14 | 1975.7 (1565.8 to 2493.0) | 1865.0 (1463.9 to 2375.9) |
| OPSONO-18C | 1694.1 (1188.6 to 2414.7) | 1548.7 (1096.3 to 2188.0) |
| OPSONO-19F | 344.5 (223.0 to 532.3) | 469.7 (320.0 to 689.4) |
| OPSONO-23F | 3199.8 (2543.7 to 4025.1) | 3198.1 (2526.5 to 4048.4) |
Anti-PD antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to 100 EL.U/mL. This outcome concerns the subjects who received the RTS,S or Engerix-B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups.
| EL.U/mL | RTS,S Regimen A Group | Engerix B Regimen A Group |
|---|---|---|
| Anti-protein D (PD) Antibody Concentrations at Month 3 | 2435.3 (2204.3 to 2690.6) | 2956.7 (2647.5 to 3302.1) |
Anti-PD antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to 100 EL.U/mL. This outcome concerns the subjects who received the RTS,S or Engerix -B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix -B Regimen A groups.
| EL.U/mL | RTS,S Regimen A Group | Engerix B Regimen A Group |
|---|---|---|
| Anti-protein D (PD) Antibody Concentrations at Month 17 | 2648.3 (2194.2 to 3196.4) | 2819.1 (2391.1 to 3323.7) |
The antibodies against BPT assessed were against pertussis toxoid (anti-PT), against filamentous haemagglutinin (anti-FHA), and against pertactin (anti-PRN). Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to (\>=) 5 EL.U/mL. The table shows results for study groups pooled by primary vaccine administered (RTS,S vs Engerix -B)
| EL.U/mL | RTS,S Group | Engerix B Group |
|---|---|---|
| Anti-PT - At Day 0 | 3.8 (3.6 to 4.1) | 4.3 (3.9 to 4.8) |
| Anti-PT - At Month 3 | 105.9 (99.2 to 113.1) | 114.2 (104.8 to 124.5) |
| Anti-FHA - At Day 0 | 13.9 (12.7 to 15.2) | 15.7 (14.1 to 17.5) |
| Anti-FHA - At Month 3 | 271.1 (252.8 to 290.8) | 292.9 (268.9 to 319.1) |
| Anti-PRN - At Day 0 | 3.2 (3.0 to 3.4) | 3.2 (3.0 to 3.5) |
| Anti-PRN - At Month 3 | 164.1 (153.6 to 175.3) | 179.7 (164.4 to 196.5) |
Anti-Rotavirus (anti-RV) antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs). The cut-off of the assay was the seropositive cut-off value of greater than or equal to (\>=) 20 units per milliliter (U/mL). This outcome measure was assessed in subjects who were administered Rotarix as part of an EPI regimen, with and without RTS,S vaccine co-administration. This outcome concerns the subjects who received the RTS,S or Engerix-B vaccine co-administered with Rotarix. Results presented are for the study groups pooled by RTS,S or Engerix-B vaccine co-administration, that is, for the RTS,S Regimen B and Engerix-B Regimen B groups.
| U/mL | RTS,S Regimen B Group | Engerix B Regimen B Group |
|---|---|---|
| Anti-Rotavirus (Anti-RV) Antibody Concentrations | 24.9 (19.3 to 32.0) | 27.6 (20.8 to 36.5) |
Assessed solicited local symptoms were pain, redness and swelling at the site of injection. All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination. Analysis for this outcome was performed solely for the 7-days follow-up periods following the primary vaccination with RTS,S vaccine or Engerix-B (at Day 0, and Months 1 and 2). Data presented are those for any occurrence of the assessed solicited local symptoms, that is, the occurrences of these symptoms regardless of their intensity grade.
| Participants | RTS,S Regimen A Group | RTS,S Regimen B Group | RTS,S Regimen C Group | Engerix B Regimen A Group | Engerix B Regimen B Group |
|---|---|---|---|---|---|
| Pain - Post D1 | 41 | 28 | 31 | 29 | 15 |
| Pain - Post D2 | 30 | 14 | 21 | 24 | 9 |
| Pain - Post D3 | 14 | 10 | 14 | 18 | 7 |
| Redness - Post D1 | 1 | 0 | 2 | 5 | 1 |
| Redness - Post D2 | 5 | 1 | 2 | 3 | 0 |
| Redness - Post D3 | 3 | 0 | 1 | 3 | 0 |
| Swelling - Post D1 | 5 | 2 | 6 | 10 | 4 |
| Swelling - Post D2 | 8 | 3 | 4 | 9 | 4 |
| Swelling - Post D3 | 7 | 2 | 6 | 11 | 3 |
Assessed solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. Fever was defined as axillary temperature higher than (\>) 37.5 degrees Celsius (°C). Analysis for this outcome was performed solely for the 7-days follow-up periods following the primary vaccination with RTS,S vaccine or Engerix-B (at Day 0, and Months 1 and 2). Data presented are those for any occurrence of the assessed solicited general symptoms, that is, the occurrences of these symptoms regardless of their intensity grade or relationship to vaccination.
| Participants | RTS,S Regimen A Group | RTS,S Regimen B Group | RTS,S Regimen C Group | Engerix B Regimen A Group | Engerix B Regimen B Group |
|---|---|---|---|---|---|
| Fever - D1 | 44 | 20 | 16 | 23 | 13 |
| Fever - D2 | 30 | 14 | 18 | 20 | 5 |
| Fever - D3 | 38 | 20 | 26 | 16 | 12 |
| Irritability - D1 | 15 | 11 | 11 | 9 | 5 |
| Irritability - D2 | 13 | 7 | 12 | 10 | 0 |
| Irritability - D3 | 5 | 3 | 10 | 6 | 1 |
| Drowsiness - D1 | 2 | 1 | 3 | 3 | 0 |
| Drowsiness - D2 | 5 | 1 | 1 | 3 | 0 |
| Drowsiness - D3 | 3 | 0 | 2 | 1 | 0 |
| Loss of appetite - D1 | 4 | 1 | 2 | 4 | 0 |
| Loss of appetite - D2 | 3 | 1 | 1 | 3 | 0 |
| Loss of appetite - D3 | 2 | 0 | 1 | 1 | 1 |
A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison's disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis.
| Participants | RTS,S Regimen A Group | RTS,S Regimen B Group | RTS,S Regimen C Group | Engerix B Regimen A Group | Engerix B Regimen B Group |
|---|---|---|---|---|---|
| Number of Subjects With Potential Immune Mediated Disorders (pIMDs) From Day 0 to Month 8 | 0 | 0 | 0 | 0 | 0 |
A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison's disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis.
| Participants | RTS,S Regimen A Group | RTS,S Regimen B Group | RTS,S Regimen C Group | Engerix B Regimen A Group | Engerix B Regimen B Group |
|---|---|---|---|---|---|
| Number of Subjects With Potential Immune Mediated Disorders (pIMDs) From Day 0 to Month 26 | 0 | 0 | 0 | 0 | 0 |
A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison's disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis.
| Participants | RTS,S Regimen A Group | RTS,S Regimen B Group | RTS,S Regimen C Group | Engerix B Regimen A Group | Engerix B Regimen B Group |
|---|---|---|---|---|---|
| Number of Subjects With Potential Immune Mediated Disorders (pIMDs) From Day 0 up to Study End (Month 51) | 0 | 0 | 0 | 0 | 0 |
An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
| Participants | RTS,S Regimen A Group | RTS,S Regimen B Group | RTS,S Regimen C Group | Engerix B Regimen A Group | Engerix B Regimen B Group |
|---|---|---|---|---|---|
| Number of Subjects With Unsolicited Adverse Events (AEs) | 121 | 115 | 120 | 120 | 105 |
A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.
| Participants | RTS,S Regimen A Group | RTS,S Regimen B Group | RTS,S Regimen C Group | Engerix B Regimen A Group | Engerix B Regimen B Group |
|---|---|---|---|---|---|
| Subject with SAE(s) | 1 | 3 | 3 | 1 | 3 |
| Subjects with fatal SAE(s) | 1 | 0 | 1 | 0 | 0 |
A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.
| Participants | RTS,S Regimen A Group | RTS,S Regimen B Group | RTS,S Regimen C Group | Engerix B Regimen A Group | Engerix B Regimen B Group |
|---|---|---|---|---|---|
| Subjects with SAE(s) | 1 | 7 | 7 | 3 | 5 |
| Subjects with fatal SAE(s) | 1 | 2 | 2 | 0 | 0 |
A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.
| Participants | RTS,S Regimen A Group | RTS,S Regimen B Group | RTS,S Regimen C Group | Engerix B Regimen A Group | Engerix B Regimen B Group |
|---|---|---|---|---|---|
| Any SAEs - At Month 26 | 1 | 8 | 7 | 6 | 6 |
| Fatal SAEs - At Month 26 | 1 | 3 | 2 | 2 | 1 |
A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject. A related SAE was defined as a SAE assessed by the investigator as being causally related to vaccination.
| Participants | RTS,S Regimen A Group | RTS,S Regimen B Group | RTS,S Regimen C Group | Engerix B Regimen A Group | Engerix B Regimen B Group |
|---|---|---|---|---|---|
| Any SAEs | 3 | 10 | 9 | 6 | 6 |
| Fatal SAEs | 3 | 5 | 4 | 2 | 1 |
Collected over Solicited local, general symptoms and unsolicited AEs: within the 30-day periods after primary co-administration vaccination. SAEs: during the entire study period (Month 0 to Month 51).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RTS,S Regimen A Group | 3/142 (2.1%) | 3/142 (2.1%) | 135/142 (95.1%) |
| RTS,S Regimen B Group | 5/142 (3.5%) | 10/142 (7%) | 129/142 (90.8%) |
| RTS,S Regimen C Group | 4/141 (2.8%) | 9/141 (6.4%) | 132/141 (93.6%) |
| Engerix B Regimen A Group | 2/141 (1.4%) | 6/141 (4.3%) | 135/141 (95.7%) |
| Engerix B Regimen B Group | 1/139 (0.7%) | 6/139 (4.3%) | 119/139 (85.6%) |
| Event | RTS,S Regimen A Group | RTS,S Regimen B Group | RTS,S Regimen C Group | Engerix B Regimen A Group | Engerix B Regimen B Group |
|---|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 1/142 | 0/142 | 1/141 | 3/141 | 2/139 |
| GastroenteritisInfections and infestations | 1/142 | 1/142 | 2/141 | 0/141 | 1/139 |
| MalariaInfections and infestations | 1/142 | 2/142 | 2/141 | 2/141 | 1/139 |
| PneumoniaInfections and infestations | 1/142 | 2/142 | 2/141 | 2/141 | 1/139 |
| BronchiolitisInfections and infestations | 0/142 | 0/142 | 0/141 | 0/141 | 1/139 |
| BronchitisInfections and infestations | 0/142 | 1/142 | 1/141 | 0/141 | 1/139 |
| Escherichia urinary tract infectionInfections and infestations | 0/142 | 0/142 | 0/141 | 0/141 | 1/139 |
| Febrile convulsionNervous system disorders | 0/142 | 1/142 | 1/141 | 1/141 | 1/139 |
| Hypertrophic cardiomyopathyCongenital, familial and genetic disorders | 0/142 | 0/142 | 1/141 | 0/141 | 0/139 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 0/142 | 0/142 | 0/141 | 1/141 | 0/139 |
| Event | RTS,S Regimen A Group | RTS,S Regimen B Group | RTS,S Regimen C Group | Engerix B Regimen A Group | Engerix B Regimen B Group |
|---|---|---|---|---|---|
| PyrexiaGeneral disorders | 81/142 | 49/142 | 50/141 | 55/141 | 34/139 |
| PainGeneral disorders | 55/142 | 40/142 | 47/141 | 48/141 | 25/139 |
| GastroenteritisInfections and infestations | 42/142 | 47/142 | 51/141 | 43/141 | 38/139 |
| MalariaInfections and infestations | 44/142 | 44/142 | 39/141 | 49/141 | 44/139 |
| BronchitisInfections and infestations | 36/142 | 33/142 | 28/141 | 28/141 | 29/139 |
| RhinitisInfections and infestations | 32/142 | 35/142 | 33/141 | 31/141 | 31/139 |
| IrritabilityPsychiatric disorders | 28/142 | 18/142 | 27/141 | 19/141 | 5/139 |
| SwellingGeneral disorders | 17/142 | 7/142 | 14/141 | 23/141 | 10/139 |
| PharyngitisInfections and infestations | 23/142 | 13/142 | 15/141 | 15/141 | 17/139 |
| ErythemaSkin and subcutaneous tissue disorders | 19/142 | 8/142 | 20/141 | 12/141 | 6/139 |
| Age, Continuous(Weeks) | RTS,S Regimen A Group | RTS,S Regimen B Group | RTS,S Regimen C Group | Engerix B Regimen A Group | Engerix B Regimen B Group | Total |
|---|---|---|---|---|---|---|
| Mean | 8.4 ± 0.83 | 8.3 ± 0.62 | 8.3 ± 0.69 | 8.3 ± 0.74 | 8.3 ± 0.74 | 8.32 ± 0.73 |
| Sex: Female, Male(Participants) | RTS,S Regimen A Group | RTS,S Regimen B Group | RTS,S Regimen C Group | Engerix B Regimen A Group | Engerix B Regimen B Group | Total |
|---|---|---|---|---|---|---|
| Female | 59 | 69 | 67 | 81 | 63 | 339 |
| Male | 83 | 73 | 74 | 60 | 76 | 366 |
| Race/Ethnicity, Customized(Participants) | RTS,S Regimen A Group | RTS,S Regimen B Group | RTS,S Regimen C Group | Engerix B Regimen A Group | Engerix B Regimen B Group | Total |
|---|---|---|---|---|---|---|
| African Heritage/African American | 142 | 142 | 141 | 141 | 139 | 705 |
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Supporting information: Study protocol, Sap, Icf, Csr
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